This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Continued support is requested for the Clinical Research Center(CRC) through the Research Center for Minority Institutions (RCMI) Clinical Research Infrastructure Initiative. The CRC at the Morehouse School of Medicine (MSM) was the first major step in embarking the institution on fulfilling its mission of improving the health of the underserved minority population in the area of patient care. As a young institution, MSM recognizes the long history that clinical research centers have played in improving the standards of health care in America as well as globally. The presence of the CRC at MSM has had great influence upon the faculty to focus research on those health problems that disproportionately affect minorities and underserved populations of the U.S. This has led to greater collaboration between the basic science faculty and the clinical faculty in research endeavors. It has further led to collaborations for training and/or research of clinical faculty with Harvard University School of Medicine, Centers for Disease Control (CDC), Emory University, Georgia State University, Boston University, University of Alabama and Fulton County Department of Health and Wellness. During the last four years of the RCMI, support for the CRC clinical research activities at MSM has increased from 4 to 27 Public Health Service (PHS) - funded clinical research - oriented studies (67% increase), with a number under review. Research projects supported through the CRC increased from zero during 1995-96 academic year to 12 in 1998-99. Continued support is requested to aid MSM in continuation of its effort to build a research program in clinical research to make it competitive for research support from government and private foundations. In this application, we are requesting continued support of the Administrative and Clinical Core, with additional support for the Informatics, and Recruitment Core. This will enhance our ability to support and coordinate clinical studies at multiple clinical sites. This will also allow the CRC to coordinate extramural studies at multiple clinical sites. Progress 2002 The Clinical Research Center at Morehouse School of Medicine has continued on a trajectory of research productivity and growth: 1. traditional benchmarks of research productivity 2. expansion and increased utilization of the centers core facilities (analytical, biostatistics, nursing/recruitment, ultrasound) 3. internal multidisciplinary collaborations 4. community partnerships 5. external collaborations 6. clinical research education curriculum development Research Productivity: CRC investigators published 35 manuscripts in the current grant cycle, compared with 22 from the previous cycle;31 new grants were funded, compared with 16 from the previous year of the 47 active protocols in the center;80% are investigator- initiated, and 70% are funded by the NIH. Multidisciplinary Collaborations: CRC investigators in collaboration with other MSM departments, centers and institutes launched three major initiatives: The EXPORT program is funded by the National Center for Minority Health The Stroke Prevention Intervention Research Program (SPIRP) is jointly- funded by the NINDS, NCRR and NHCB The BioInformatics Infrastructure Initiative was jointly developed by the RCMI, RCII (CRC) programs, in collaboration with basic science departments and centers. Community Partnerships (CPN) A Community Practice Network has been established to expand the clinical research patient and investigator base of the CRC. This program recently received additional funding from the Medtronic Foundation. A continuing success story is the Community Advisory Board, to promote awareness of the benefits of clinical research, and to increase the recruitment of African American patients into MSM research studies. Clinical Research Education and Curriculum Development (CRECD) This program will enter its second year of a projected five- year funding cycle in September 2003. Nine junior faculty from five clinical departments (Internal Medicine, Community Health and Preventive Medicine, Family Medicine and Pediatrics) are pursuing rigorous didactic coursework and mentored research projects in the following areas: External Collaborations (grants or program area) Emory University (Reynold's Foundation application) University of Alabama Birmingham (Cancer Research;CRECD) Duke University (Community Practice Network;CRECD) Boston University (SCOR in ischemic heart disease) University of Virginia Charlottesville (CCRE program) St. Louis University (CCRE program) Progress 2003-2004 The Clinical Research Center (CRC) has three primary objectives: The following summarizes major functions and accomplishments in the current year. 1. Provide an infrastructure necessary to conduct quality clinical research. 2. Increase the number and quality of clinicians actively engaged in clinical research through focused training and faculty development programs. 3. Encourage and facilitate research collaborations between basic scientists and clinicians. The CRC has been very productive in traditional benchmarks such as publications and grants. Annual research productvity includes submission of 15 manuscripts and grants. . The Biostatistical and Data Management Core (BDMC) serves as a shared MSM resource in support of internal and external research collaborations. These core activities assure scientific merit and quality of research projects and are critically important to the overall productivity of any research program. For 2003, this unit provided expert consultation to 32 investigators here on the MSM campus and 13 extramurally. The Cardiovascular Ultrasound-Imaging Core (CUIC) serves as a key component of the needed cardiovascular research infrastructure in evaluating the mechanisms of heart muscle and blood vessels changes in hypertension and its complications. The Ultrasound Imaging Core supports 10 major resource projects funded by various agencies, including NASA and NIH. The Recruitment Core has expanded its role to the community to include a Community Advisory Board, and a weekly radio broadcast. In addition to helping to recruit participants into clinical research, the unit also provides considerable community education through multiple health screening events in local churches, job fairs and malls. The University of Alabama at Birmingham is collaborating with the CRC on this core. In year 2003, this team was able to screen 1873 potential participants, with 612 actually enrolled into various MSM/CRC trials. The Analytical Laboratory provides analytical assistance to MSM investigators by developing/modifying and standardizing methods essential to their respective research projects. Over the past year, this lab has processed 611 samples for investigators such as Drs. Bradford, I. Abukhalaf, M. Bayorh, J. Menter, L. Penix, W. Royal, J. Hibbert, and E. Ofili. The Nursing/Coordinator Core support is provided by a staff of highly motivated, skilled professionals who possess diverse experience in such areas as Critical Care, Cardiology, Gerontology, and Medical-Surgical. They collect research data, perform focused research, and patient care assessments, and process blood, urine and other biological specimens. In conjunction with the Administrative Director, this core supports 20 NIH and industry supported research studies. The Master of Science in Clinical Research is in its second year and central to our efforts to increase the number and quality of clinical researchers at MSM. It is accredited and fully integrated into the GEBS program. Collaborations with the University of Alabama Birmingham;Duke University;NIH and University of Rochester are important accomplishments this year. The first four fellows will graduate in May 2004 and are expected to win additional research awards to continue their career development The Clinical Research Center of Excellence (CCRE) Award (October 1999) to Morehouse School of Medicine has allowed considerable expansion of the infrastructure of the Clinical Research Center through the establishment of several core facilities or programs: Genetic Epidemiology Program, Ultrasound Core Laboratory. The CCRE provides a milieu for the mentoring of junior investigators. The Community Practice Network (CPN) is a first of its kind, and promises to revolutionize clinical research practice and application in the African-American community. The CRC received pilot funding from the Health Disparities Center Initiative (National Center for Minority Health). The Medtronic Foundation has given a $1 million gift to help the Community Practice Network establish clinical practice Registries to support patient, physician education and clinical trials. In year 1 and 2, we will focus on the hypertension and heart failure registry. A major goal of the NIH is for the Clinical Research Center at Morehouse School of Medicine and other RCMI institutions to develop sufficient capacity with NIH funded investigators and projects in order to compete for a GCRC award (General Clinical Research Center). It is important to recognize that the Morehouse School Of Medicine Clinical Research Center has grown into a broad umbrella organization that supports activities beyond what typical General Clinical Research Centers support. In addition to the biostatistics, analytical laboratory and nursing support of traditional General Clinical Research Centers, Morehouse School of Medicine Clinical Research Center also has an accredited clinical research training program, a health services research component through the Program of Healthcare Effectiveness Research, community outreach through the Community Practice Network and the participant recruitment core. Such an umbrella structure allows the Clinical Research Centers to integrate resources across its various units, and leverage existing resources to attract new funds for the center. The Center of Clinical Research Excellence (CCRE) is one such unit that has significantly increased research capacity at the CRC. In the CCRE model, established investigators interact with junior investigators, using Clinical Research Center and CCRE core laboratory support. The CCRE model has been critical to the success of the recently- established Master of Science in Clinical Research Program. The Clinical Research Center program priorities for FY 2004 and 2005 were to: 1. Expand and institutionalize the Community Practice Network (CPN) as a resource for physicians and participant education and recruitment for Morehouse School Of Medicine sponsored clinical trials. 2. Develop a clinical research informatics network for support of the Community Practice Network. 3. Establish the Biostatistical core as a Data Coordinating Center that will serve multi-center and multi-institutional protocols. 4. Secure renewal funds for the CCRE (4/04) and CRC (4/05). 5. Expand the Clinical Research Center investigator and project base. 6. Seek additional funds to support and expand the Masters of Science in Clinical Research (MSCR) Program. 7. Expand the CRC recruitment core, with appropriate links to the Office of Public Affairs and other Morehouse School of Medicine community resources.